Sr Reliability Engineer

Medtronic plc; Lafayette (CO); Presencial; USD 107.000 - 161.000; Jornada completa

Descripción de la vacante

Medtronic plc is seeking a Senior Supplier / Manufacturing Quality Engineer for NPD to influence manufacturability, set up robust supplier processes, and ensure supply continuity. You will lead supplier qualification, PPAP, CAPA, and process validation across plastics, metals, electronics, and assemblies in a regulated medical device environment.

The role requires collaboration with internal and external suppliers, strong problem-solving and communication skills, and occasional travel to meet

Formación

• Bachelor’s degree in engineering or related technical field with 4+ years of relevant experience (or advanced degree with 2+ years).
• Extensive understanding of manufacturing processes for plastics, metals, electronics and assembly; GD&T, FMEA, DFX knowledge.
• Regulated environment experience with strong analytical and problem-solving skills; effective cross-functional communication and leadership.

Responsabilidades

• Select and qualify suppliers; ensure delivery of quality parts and services.
• Monitor parts through the manufacturing cycle; identify and resolve supplier-related issues.
• Evaluate supplier capabilities to meet product, process, and quality requirements; input to supplier selection.
• Manage Non-Conformance Material Reports (NCMRs) across incoming, production, and sterilization areas; drive root-cause analysis.
• Manage supplier change requests; lead projects and regular reporting.
• Oversee PPAP qualification including validation, testing, and technical documentation.
• Drive supplier performance improvements and reduce escapes via CAPA and quality reviews.
• Oversee IQ/OQ/PQ validation and master validation planning in NPD.
• Collaborate cross-functionally to capture design controls and manufacturability considerations.

Educación

Bachelor's or advanced degree in engineering

Herramientas

SAP

Trackwise

Windchill

Agile

Descripción del empleo

We anticipate the application window for this opening will close on - 27 Nov 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Job Title: Senior Supplier / Manufacturing Quality Engineer -- NPD

Location:

Company: Medtronic

Job Description:

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Quality Engineer to join our innovative team. This role will be in the Surgical Operating Unit within the new product development quality team to influence design based on manufacturability, inspection and assembly, interact with suppliers (internal and external) to develop robust processes to manufacture the parts and assemblies, qualify the manufacturing processes established to produce sustainable supply and maintain supply and manufacturing continuity until product transfer. The ideal candidate will bring a strong background in manufacturing processes, manufacturing process development, process controls, process validation and supplier management. The role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that drive successful design transfer.

Key Responsibilities:

• Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Evaluate supplier technical and manufacturing capabilities to meet product, process, quality, and business requirements as an input to supplier selection.
• Manage Non-Conformance Material Reports (NCMRs) for material, components and production related issues, ensuring trends are identified, analyzed, and addressed across incoming, production, and sterilization areas.
• Manage suppliers' change requests, including communication, project management, and regular reporting.
• Manage the Approved Supplier List, from supplier evaluation, supplier agreement, supplier audits to supplier acceptance.
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• Drive supplier performance improvement and reduce escapes to manufacturing through effective issue escalation, Supplier CAPA management, and Quality Performance Reviews.
• Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.
• Perform Statistical analysis of manufacturing process performance outputs
• Oversee Process Failure Mode and Effect Analysis (internally and externally)
• Collaborate cross functionally to ensure process limitations are captured within the design control, including Design Failure Mode and Effects Analysis and Design for Manufacturability and Assembly activities.
• Collaborate cross functionally to ensure essential components, product features and respective process controls are identified.
• Ensure Design Transfer effectively translates design specifications into production specifications.
• Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.
• The job requires occasional travel to visit suppliers within the United States and internationally.

Qualifications:

Minimum Requirements:

• Education: Minimum bachelor’s degree in engineering, or a related technical field AND minimum 4 years of relevant experience. OR advanced degree with a minimum of 2 years relevant experience.
• Technical Knowledge: Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly. Extensive understanding of GD&T, FMEA, DFX principles.
• Regulatory Knowledge: Extensive experience in a regulated environment.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications:

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics. Lead auditor experience.
• Other: Basic knowledge of human anatomy/physiology and surgical procedures
• Tools: SAP, Trackwise, Windchill, Agile

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of Professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Medtronic Benefits And Compensation Plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.